Observational Study on Skin Toxicity by Oncological Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 20
- 主要终点
- Evaluation of the severity of skin toxicities related to oncological treatment
研究概览
简要总结
This is a multicenter, retrospective and prospective observational study. The project involves the collection of clinical data of patients treated with oncological therapies, to evaluate skin toxicities related to oncological treatment.
详细描述
This is a multicenter, retrospective and prospective observational study. The research will include 300 patients treated with clinical practice oncological treatments (approved by Italian Competent Authority, AIFA) from January 2012 to February 2024.
Patients will follow the prescribed therapeutic indications according to regular clinical practice and data from their medical records will be collected in a study database.
Primary objective of the study is the evaluation of the type, frequency and severity of skin toxicities related to oncological treatment.
Secondary objectives are:
- Evaluation of the association between skin toxicities due to oncological treatment and drug activity and effectiveness parameters(ORR, PFS, OS);
- Evaluation of the association between clinical-pathological features of primary cancer and skin toxicities of oncological treatment;
- Evaluation of the optimal management of skin toxicities related to cancer treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who have signed informed consent.
- •Consecutive retrospective patients and prospective patients treated with new clinical practice oncological treatments (approved by AIFA) from January 2012 to February 2024
- •Male or female, age ≥18 years.
排除标准
- •Participation in another clinical trial with any investigational drug.
结局指标
主要结局
Evaluation of the severity of skin toxicities related to oncological treatment
时间窗: 5 years
Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.
Evaluation of the frequency of skin toxicities related to oncological treatment
时间窗: 5 years
Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.
Evaluation of the type of skin toxicities related to oncological treatment
时间窗: 5 years
Data will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers. Specific types of skin toxicities will be defined during dermatologists involved in the study, based on subjects enrolled at each site.
次要结局
- Evaluation of the association between skin toxicities and objective response rate(5 years)
- Evaluation of the association between skin toxicities and overall survival(5 years)
- Evaluation of the association between skin toxicities and progression-free survival(5 years)
- Evaluation of the optimal management of skin toxicities related to cancer treatment(5 years)
- Evaluation of the association between skin toxicities and baseline clinical parameters(5 years)